Summary: Fresenius Kabi warns of potential pneumatic valve failures in certain Ivenix LVPs, urging providers to remove affected devices for repair. Failure could delay therapy or cause underdosing, risking serious harm. The FDA acknowledges the alert; users should follow recommended precautions, monitor patients closely, and regularly check for updated guidance online.

Key Takeaways:

  • Certain Ivenix LVP pneumatic valves may fail, causing therapy delays or underdosing and necessitating prompt removal for repair.
  • Providers should adhere to Fresenius Kabi’s guidelines—removing affected units, closely monitoring patients, having backups ready, and keeping informed through FDA updates—to ensure patient safety.

Fresenius Kabi has reported that a subset of pneumatic valves installed in some Ivenix LVPs have an increased chance of issuing a non-recoverable pump problem alarm. The company has issued an early alert telling users of devices with the affected valves to remove them from use to be evaluated and returned to Fresenius Kabi’s facility for repair.

Potential Risks of Valve Failure

If the affected Ivenix LVP’s pneumatic valve fails, a Pump Problem alarm will be raised. If the failure occurs during LVP setup, it could potentially delay therapy. If the failure occurs during an active infusion and flow is interrupted, it could lead to an underdose. Delay or interruption of a life-sustaining infusion may result in permanent disability or death. Fresenius Kabi indicated that the pump problem alarms are working as intended and will arise indicating when to act if the malfunction occurs. The firm has not reported any injuries or deaths associated with this issue.

Device Description

The Ivenix LVP is a large volume infusion pump designed to deliver fluids and medications from one of two inlet source containers to the patient through a single outlet. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient.

RELATED: Fresenius Kabi Issues Limited Ivenix LVP Recall

On December 5, 2024, Fresenius Kabi USA sent all affected customers a letter recommending the following actions to be taken until the affected LVPs are returned for pneumatic valve repair:

  • Review the list of affected serial numbers and post the list in a public place. If possible, remove and isolate all affected devices from circulation to prevent inadvertent use.
  • If removing all or some of the devices from active use is not feasible (that is, no alternative pumps are available and patient care would be compromised), proceed with caution as outlined below:
    • If the Ivenix LVP is being used to deliver life-sustaining medications, enhance clinical monitoring during use and ensure an additional LVP is available for situations where an interruption in infusion could be dangerous. If a problem is encountered, remove the pump from circulation, use the backup LVP to continue, and report the event to Fresenius Kabi.
    • For Pump Problem alarm during set up, use another LVP and report the issue to your institution’s biomedical engineers. Remove the pump from circulation and report the event to Fresenius Kabi.
    • For Pump Problem alarm during use, reprogram the infusion on another LVP and report the issue to your institution’s biomedical engineers. Remove the pump from circulation and report the event to Fresenius Kabi.
  • Post the steps above and the list of affected Serial Numbers at each nursing station.
  • Inform potential users of the product within your organization of this notification.
  • Check the FDA’s page for updates.

Regulatory Oversight

The FDA is aware that Fresenius Kabi USA has issued a letter to affected healthcare providers indicating a subset of Ivenix large-volume pumps are to be removed from use for repair and will keep the public informed and with online updates as significant new information becomes available.